This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.

The National Statement on Ethical Conduct in Human Research 2007 recognises that sponsors, investigators/researchers, institutions and HRECs all have relevant responsibilities in relation the monitoring of trials and the reporting of adverse events that may occur during clinical trials. The Position Statement, which replaced the HREC Alert of 18 April 2007, was designed to clarify the responsibilities of all parties in relation to reporting of adverse events (AE), including serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs), occurring in clinical trials for which institutions are responsible and the Human Research Ethics Committees (HRECs) have reviewed and given ethical approval.

This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.

The Code provides a framework for managing breaches of the Code and allegations of research misconduct, managing research data and materials, publishing and disseminating research findings, including proper attribution of authorship, conducting effective peer review and managing conflicts of interest. It also explains the responsibilities and rights of researchers if they witness research misconduct.

This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.

Good clinical practice (GCP) , is a set of internationally recognised ethical and scientific standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. The aim of these quality management procedures is to provide assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. The same requirements apply to Contract Research Organisations (CROs), vendors or other service providers to whom the sponsor has delegated any trial related duties and functions of the sponsor.

Quality of clinical trials: A moving target (Website)

This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.

Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

Whether you are a researcher, in a research office or just wanting to find out more about how clinical trials are conducted, these modules use interactive learning, interviews with experts and knowledge reviews to provide an overview of the nature and importance of the clinical trials environment and approval process in Australia. These modules provide an introduction to the clinical trials environment, clinical research ethics and ethical review and research governance processes and are a component of the Government’s Expediting Clinical Trials Reforms initiative to maintain Australia’s position as a world leader in quality clinical research.